How safe is metformin when initiated in early pregnancy? A retrospective 5-year study of pregnant women with gestational diabetes mellitus from India.

BACKGROUND: The initiation of metformin in early pregnancy in Gestational Diabetes mellitus (GDM) remains controversial. The aim of our study was to assess the influence of Metformin on maternal and fetal outcomes when initiated within the first trimester of pregnancy in GDM. METHODS AND MATERIALS: A retrospective analysis of 540 women with diabetes complicating pregnancy (IADPSG criteria) over five years (January 2011 to May 2016) was done. The study population comprised of patients initiated on (a) metformin within the first trimester (Group A:n = 186), (b) metformin after the first trimester (Group B:n = 203) and (c) insulin at any time during their pregnancy (Group C:n = 151). The primary outcomes compared were prematurity, respiratory distress, birth trauma, 5-min APGAR score, neonatal hypoglycaemia and need for phototherapy, while secondary outcomes compared were neonatal anthropometric measurements, maternal glycemic control, maternal hypertensive complications, postpartum glucose tolerance. RESULTS: Individual and composite primary or secondary outcomes in group A were similar to Groups B and C, though numerically higher premature births were seen in Group A. There was a 1.3% overall incidence of stillbirths/IUD, while 1.11% congenital anomalies were noted of which 2.15% were in group A and 1.32% were in Group C (p = .16). CONCLUSIONS: The initiation of metformin within the first trimester of pregnancy has no significant adverse maternal or fetal outcomes. However, vigilance for premature births is recommended in women exposed to metformin in early pregnancy.

Prevalence of XDR TB cases--a retrospective study from a tertiary care TB hospital.

BACKGROUND: The emergence of XDR -TB strains is a major roadblock in the successful implementation of TB control programmes. This further leads to high morbidity and mortality, especially in immuno-compromised patients. Identification and observation of resistance patterns of XDR-TB strains may help clinicians manage MDR-TB cases, the treatment line of which is expensive, time-taking and involves intake of toxic drugs with many side-effects. Our study is aimed to find out the prevalence of XDR-TB among the MDR-TB strains isolated in a tertiary care hospital. MATERIAL & METHODS: The study population consisted of 223 patients of tuberculosis who were culture positive and Mycobacterium tuberculosis was resistant to Rifampicin and Isoniazid during January 2007 to December 2009. Each patient had submitted two sputum samples i.e. spot and morning. The identified Mycobacterium tuberculosis complex was subjected to drug sensitivity testing by first and second line drugs by proportion and absolute concentration methods as per standard procedure. RESULTS: The results showed that 20.17% strains (45/223) were XDR-TB strains. Most of these strains showed resistance to four drug combination viz. KM, ETH, OFX & PAS (5.82%), KM & OFX (3.13%), OFX, KM and ETH (1.79%), 1.34% strains showed resistance to all the drugs i.e. pan resistance and other combinations in the remaining strains. Nearly 80% of the XDR-TB strains showed resistance to three or more drugs combination pattern. CONCLUSION: The multidrug resistant TB cases need urgent and timely sensitivity report for second line ATT drugs to help clinicians start proper drug combinations to treat MDR-TB patients.

Smear microscopy as surrogate for culture during follow up of pulmonary MDR-TB patients on DOTS Plus treatment.

BACKGROUND: DOTS Plus site at LRS Institute, New Delhi, covering 1.8 million population. AIMS: To ascertain if sputum smear could be used as a surrogate for culture during intensive phase of treatment of MDR-TB patients thereby enabling early shift from intensive phase to continuation phase, reducing the need for frequent cultures and saving time and cost in their management. METHODS: The study is a retrospective analysis of 138 MDR-TB patients on DOTS Plus treatment whose sputum samples were simultaneously subjected to smear microscopy and culture, monthly during Intensive Phase and once in two months during Continuation Phase. Sputum results in the treatment card were supplemented from laboratory register, if required, and analyzed. Predictive values, sensitivity and specificity of smear were compared with culture results. RESULTS: The Negative Predictive Value (NPV) of smear was high from the 3rd month onwards (above 91%), at four months 98% or more and approached 100% from eight months onwards. The specificity of smear test gradually increased during treatment and from five months onwards, it was above 90%. CONCLUSIONS: Considerable correlation was observed between sputum smear and culture during follow up of DOTS Plus treatment in the Intensive Phase. Accordingly, sputum smears can be recommended instead of culture.

Seven-year DOTS-Plus pilot experience in India: results, constraints and issues.

BACKGROUND: India is initiating the DOTS-Plus strategy at the national level. OBJECTIVES: To highlight the results, constraints and issues of a pilot DOTS-Plus experience in an urban setting in India. METHODS: Records of 126 patients with multidrug-resistant tuberculosis (MDR-TB) enrolled from January 2002 to December 2006, who received a daily fully supervised standardised treatment regimen under a pilot DOTS-Plus study in India, were analysed retrospectively. RESULTS: Of the 126 patients enrolled, 61% were cured, 19% died, 18% defaulted and 3% failed treatment. There was an average delay of 5 months in the diagnosis of MDR-TB and a subsequent delay of approximately 3.3 months in initiating treatment. Of the 24 patients who died, 29% did so within a month of starting treatment. Migration was the most common reason for default. Cycloserine (CYC) had to be stopped in 15 patients and kanamycin (KM) in five due to major adverse effects. CONCLUSIONS: The DOTS-Plus programme in resource-poor settings may provide reasonable results; however, it may confront significant operational difficulties in the timely diagnosis and early initiation of treatment. Early diagnosis and start of treatment may prevent some deaths. Default is commonly due to migration. CYC proved to be the most toxic drug, followed by KM.

Risk factors for new pulmonary tuberculosis patients failing treatment under the Revised National Tuberculosis Control Programme, India.

SETTING: Tertiary level tuberculosis (TB) institute in Delhi, India. OBJECTIVE: To study the risk factors for new pulmonary TB (PTB) patients failing treatment. DESIGN: Prospective case-control study. The profile of new PTB patients failing treatment (i.e., sputum smear-positive at 5 months of treatment) and responders under the Revised National Tuberculosis Control Programme (RNTCP) were compared and risk factors associated with treatment failure were analysed. RESULTS: A total of 42 treatment failure cases and 76 controls were enrolled in the study. The presence of cavity on chest X-ray (CXR), sputum acid-fast bacilli (AFB) smear positivity at 2 months of treatment and the number of interruptions in treatment were independently associated with failures. Among failure patients at 5 months, 17 (40.5%) had negative sputum culture for Mycobacterium tuberculosis, and only six (14.3%) had multidrug-resistant TB (MDR-TB). When put on retreatment, patients with smear-positive, culture-negative sputum had cure rates of 88.2% compared to 28.6% among culture-positive patients. CONCLUSIONS: The presence of cavity on CXR, sputum smear positivity at 2 months of treatment and the number of interruptions of treatment are risk factors for failure. Among failures based on smear examination, the prevalence of MDR-TB is low and many patients have negative cultures for M. tuberculosis. Smear positivity at the end of treatment may not be a reliable indicator of treatment failure.

A thyroid tubercular abscess and bilateral symmetrical hilar lymphadenopathy: a rare association.

An 18-year-old boy presented with a rare association of a thyroid tubercular abscess and bilateral symmetrical hilar lymphadenopathy. He was put on a Category I regimen with standard short course daily chemotherapy of four anti-tubercular drugs under the National Tuberculosis Programme. After a six-month of anti-tubercular treatment (ATT), the boy showed clinical and bacteriological improvement. The thyroid scan with Technetium 99 (Tc 99) and the chest skiagram also became normal.

Multi-drug resistant tuberculosis in context of RNTCP.

DOTS has been successful in improving cure rates in tuberculosis worldwide, but has remained an inefficient strategy in respect of multidrug-resistant tuberculosis (MDR TB). The present article discusses its management in context of RNTCP and focuses specially on DOTS-plus, a strategy arising out of the constitution of Green Light Committee to effectively tackle the cases of MDR TB globally.